GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES

Latex Patient Examination Glove

GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD

The following data is part of a premarket notification filed by Guthrie Medicare Products (melaka) Sdn Bhd with the FDA for Guthrie Prime Powder-free Chlorinated Patient Examination Gloves.

Pre-market Notification Details

Device IDK000090
510k NumberK000090
Device Name:GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-13
Decision Date2000-02-10

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